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PD-L1

BiomarkerProtein Expression

PD-L1 expression is used to guide immune checkpoint inhibitor therapy. Expression thresholds vary by tumor type and therapy.

Approvals
12
Indications
7
Therapies
4
Mapped tests
4

Where this biomarker is used

Each approval combines this biomarker with a specific indication and therapy. Select a therapy in the tables below to open its FDA-defined testing pathway.

Indication-specific approvals

Approvals where PD-L1 is defined directly in the indication labeling.

IndicationBiomarker criteriaTherapies
Cervical Cancer
Solid Tumor · Cervix
  • protein expression
KEYTRUDA
Esophageal Squamous Cell Carcinoma (ESCC)
Solid Tumor · Esophagus
  • protein expression
KEYTRUDA
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Solid Tumor · Stomach/GEJ
  • protein expression
KEYTRUDA
Head and Neck Squamous Cell Carcinoma (HNSCC)
Solid Tumor · Head & Neck
  • protein expression
KEYTRUDA
Non-Small Cell Lung Cancer (NSCLC)
Solid Tumor · Lung
  • protein expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%])
  • protein expression
  • protein expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%])
  • protein expression (tumor cell staining ≥1%)
  • protein expression [Tumor Proportion Score (TPS) ≥ 50%]
LIBTAYOTECENTRIQOPDIVO + YERVOYKEYTRUDA
Triple-Negative Breast Cancer (TNBC)
Solid Tumor · Breast
  • protein expression
KEYTRUDA
Urothelial Cancer
Solid Tumor · Bladder
  • protein expression (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 5% of the tumor area)
TECENTRIQ
Tumor-agnostic approvals

Approvals defined at the solid tumor level where PD-L1 is part of the eligibility criteria.

No tumor-agnostic approvals are currently mapped for this biomarker.

Tests that measure this biomarker

These assays report PD-L1 as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.

Test
PD-L1 IHC 22C3 pharmDx
Dako North America, Inc.
Method
IHC
Specimen
Tissue (FFPE)

Reports PD-L1 as part of its biomarker panel.

7 approvalsView test profile →
Test
PD-L1 IHC 28-8 pharmDx
Dako North America, Inc.
Method
IHC
Specimen
Tissue (FFPE)

Reports PD-L1 as part of its biomarker panel.

1 approvalView test profile →
Test
Ventana PD-L1 (SP142) Assay
Ventana Medical Systems, Inc.
Method
IHC
Specimen
Tissue (FFPE)

Reports PD-L1 as part of its biomarker panel.

2 approvalsView test profile →
Test
Ventana PD-L1 (SP263) Assay
Ventana Medical Systems, Inc.
Method
IHC
Specimen
Tissue (FFPE)

Reports PD-L1 as part of its biomarker panel.

2 approvalsView test profile →
This view is scoped to PD-L1. You can also see how it compares with other biomarkers and indications on the Know Your Companions™ map.